Journal of Law, Medicine & Ethics
Journal of Law, Medicine & Ethics
New York representative Louise M. Slaughter died last week at the age of 88. She was trained as a microbiologist and was one of the longest-service members of the US House of Representatives. Among her many accomplishments was serving as lead author of the Genetic Information Nondiscrimination Act (GINA) of 2008. This landmark legislation protects individuals from genetic discrimination in health insurance and employment; it was designed to help ease discrimination concerns that might keep people from getting genetic tests that could benefit their health. The law also enables people to take part in research studies without fear that their DNA information might be used against them in health insurance or the workplace. According to Eric Green of the National Human Genome Research Institute (NHGRI), "We have truly lost a genomics champion. Louise Slaughter had the vision that GINA was needed to ensure continued advances in genetics and genomics research, especially for clinical applications — and she was completely right. Our research community will remember her commitment to these important social and ethical issues." GINA is among the laws that will be accessible via the website of the NHGRI-funded LawSeqSM project, for which Consortium chair Susan M. Wolf is Co-PI with Ellen Wright Clayton of Vanderbilt and Frances Lawrenz of the University of Minnesota. LawSeqSM is dedicated to building a legal foundation for translating genomics into clinical application; the website will go live in spring, 2018.
In a recent KARE 11 interview, Consortium Chair Susan M. Wolf discussed current challenges to research integrity and described how they can be addressed. The news report hints at a larger set of issues that threaten to slow advances in knowledge and undermine the public’s trust in science. Last week, at the Research Integrity and Trustworthy Science conference, national experts in biomedicine, the social sciences, law, ethics, and more converged at the University of Minnesota to grapple with pressing research problems, including researcher misconduct, inadequate education of new researchers, predatory journals that fail to perform thorough peer review and oversight lapses. An article in Inquiry, the blog of the University of Minnesota Office of the Vice President for Research (VP Allen Levine is pictured), describes the conference proceedings and delves into the plenary sessions, which highlighted how research ethics rely on three parties: researchers, academic journals, and research institutions. Video of this year's sessions are available here. Information on previous annual Research Ethics conferences can be found here, here and here.
Two University of Minnesota professors have co-authored a major nutrition policy paper on behalf of the American Academy of Pediatrics (AAP).
How can we harness the big social, technological, and infrastructural changes arising in cities for the greatest good? A new National Science Foundation (NSF) report led by Anu Ramaswami outlines a long-term research agenda that uses a much larger urban systems perspective than is currently in place. Among the paradigm changes it recommends are taking rural-urban trade into account; considering the impacts of the sharing economy, automation and renewable energy; and asking how massive new urbanization expected in Africa and Asia will influence global environments. Ramaswami is the Director of the Center for Science, Technology, and Environmental Policy, a Consortium member. Read more about the report here.
Jeffrey Kahn, Director of the Berman Institute of Bioethics at Johns Hopkins University, joined Minnesota Public Radio host Kerri Miller today to discuss innovations in gene editing and the consequences that must be considered as it moves into clinical application. New tools like CRISPR are much more targeted than past gene therapies; molecular biology now allows the precoding of both the material and the location affected by genetic change. This raises thorny ethical questions: could these techniques go beyond curing diseases to creating genetic enhancements that could make someone stronger or faster? Could gene editing be used to advance eugenics, by making it possible to change someone's skin color? Will the benefits be widely available, or only help the wealthy and powerful? What does it mean to disabled if we have the ability to wipe out conditions like Down syndrome? Rapid advancements in gene therapy and the development of technologies that are more powerful than originally expected means carefully considered policy and clinical approaches must be put in place. Listen to the whole conversation here. Before joining Johns Hopkins, Prof. Kahn was Director of the Center for Bioethics at University of Minnesota.
In a talk last week sponsored by Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Prof. Francis Shen, JD, PhD, raised the question of how to grapple with powerful people who show signs of dementia. According to an item from WBUR, a public radio station in Boston, Shen's central point was that "politicians, who have huge advantages as incumbents, and federal judges, who serve for life, tend to stay on the job well past typical retirement ages. Yet we know that some cognitive decline with age is normal, and that the risk of dementia skyrockets as we get older. So it's reasonable to conclude that some judges and politicians are no longer up to their tasks." Shen is a Consortium affilate faculty member who specializes in neurolaw; he's currently a fellow at Petrie-Flom. Ultimately, Shen recommended a middle way, one that doesn't involve mandatory retirement ages for elected officials and judges but also doesn't ignore the social risks of their cognitive decline. Read the entire article here.
This Friday, Oct. 13, Deborah Swackhamer, PhD (Professor Emerita, Humphrey School of Public Affairs and School of Public Health), will discuss the federal advisory committees mandated to oversee the quality and scope of the science used by the US Environmental Protection Agency (EPA). Her talk is called "Scientific Integrity in the Balance: What's at Stake?" and will be held in 105 Cargill at 3 pm on the St. Paul campus; a remote webcast is also available here (registration required). Dr. Swackhamer is a past Chair of the EPA Science Advisory Board, and is the current Chair of the Board of Scientific Counselors, and will share first-hand knowledge of how these committees have done their work, and how they are currently being used by the new Administration. This seminar is particularly timely in light of yesterday's announcement by EPA chief Scott Pruitt that his agency is taking formal steps to repeal a rule limiting greenhouse-gas admissions that was put in place under the Obama administration. From 2002-2014, Prof. Swackhamer was the director of the Water Resources Center, a Consortium member.
Mississippi Room, Coffman Union
Mississippi Room, Coffman Union
Mississippi Room, Coffman Union
New observational technologies are greatly complicating oceanographic research, even as they present tantalizing opportunities. Because they are less expensive and more networked than ship-based measurements, remotely operated vehicles like undersea drones and satellites can provide an unprecedented amount of data while democratizing the research process. However, these new tools also challenge existing maritime codes such as the United Nations Convention on the Law of the Sea. During the 2015-2016 academic year, Geography, Environment and Society PhD candidate Jessica Lehman was awarded a Consortium Research Grant to explore how these new technologies have become entangled in questions of territory, information-sharing, and politics. Lehman notes, “Concerns about global environmental crises such as climate change push scientists to collect more data and make it freely available online, but nations are concerned that these data may compromise their sovereignty, from military operations to fisheries development. To address these concerns, we can’t make assumptions about relationships between security and new technologies; we have to follow them into the world and see what they are actually doing.” Her Consortium-funded research informed her dissertation, which evaluated the interfaces between geopolitics and international oceanographic science. Lehman is currently an AW Mellon Postdoctoral Fellow in the Center for the Humanities at the University of Wisconsin, Madison; to learn more about her research, click here.
An article in the Washington Post co-authored by University of Minnesota health policy professor Sarah Gollust analyzes the bill that passed the US House of Representatives last week. Gollust and her co-researchers conducted a national survey in March asking 1,588 Americans what they knew about the Affordable Care Act (ACA, also known as Obamacare) and the proposed American Health Care Act (AHCA, also known as Trumpcare), whether their views of these programs were favorable or unfavorable, and how completely they understood each. The results? Among those surveyed, even those who were aware of the ACA requirement to purchase insurance or pay a penalty prefer the ACA to the AHCA. Of particular concern regarding the AHCA was its penalty for enrollment gaps, fines that would be paid to insurers. The authors conclude the enrollment gap could be used as an additional line of attack by anti-AHCA activists, noting "the public is already concerned about protections for people with preexisting conditions, huge cuts to the Medicaid program, and citizens losing insurance. Highlighting the AHCA’s coverage-gap penalty could drop public support further."
Marches highlighting the importance of science – both its methods and its goals – attracted massive crowds on April 22. The organizers called for the science march after the successful Women's March drew millions on January 21; the protest was a response to ominous signs from the Trump administration regarding its intention to suppress government activities related to climate change, cut research funding, and slash the budgets of federal agencies with a scientific mission. According to the New York Times, the flagship march in Washington drew large crowds (estimated at 40,000), with similar results being reported from across the nation. In St. Paul, a protest at the Capitol drew more than 10,000, and was one of 13 pro-science rallies held in Minnesota. According to the Star Tribune, "Notable events [were held] in London, Paris and Sydney. . . . Chicago, New York and Los Angeles were among the largest U.S. marches, and smaller events took place across the country."
Videos are now available for sessions held during the two research ethics conferences presented at the University of Minnesota on March 8 and 9, 2017. At these events, researchers, policymakers, bioethicists, patient advocates and other stakeholders explored best practices for research with human participants. The conferences are The Future of Informed Consent: A Century of Law, Ethics & Innovation (March 8) and The Challenges of Informed Consent in Research with Children, Adolescents & Adults (March 9). The videos are posted at z.umn.edu/researchethicsvideos for free public access.
Given the drama of the past several weeks, during which Congress wrestled with repealing, replacing or reforming the Affordable Care Act (ACA), it's an opportune time to look at the trajectory of that legislation. On March 23, the seventh anniversary of the ACA's signing, the former General Counsel for the US Department of Health and Human Services (HHS), William B. Schultz, lectured at Harvard Law School in an event sponsored by the Petrie-Flom Center. He described what he saw from his front-row seat during five years at HHS, during which time the repeal of ACA was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Mr. Schultz also considered what's likely to happen now that the Republicans have control of all branches of government and the repeal agenda is complicated by the new support for the law by voters and some Republican governors. He concluded with a discussion of health policy options for the future. A video of the lecture and discussion can be viewed here.
A 2.3% excise tax on medical devices is among the many aspects of the Affordable Care Act (ACA) likely to be repealed during the current congressional session. The tax was collected starting in 2013, with the intention of offsetting expected ACA-driven profits for companies benefiting from expanded federally-funded Medicare and Medicaid payments. However, Congress passed a two-year repeal of the tax that was enacted in 2015 in an effort led by legislators representing states, like Minnesota, with robust medical device industries. According to the Star Tribune, "With [medical device excise tax] collections set to start again in January 2018, [Republican GOP Representative Erik] Paulsen is going for the coup de grace with a GOP-controlled House, Senate and White House that have made repealing the ACA a top priority." The article notes that the bill's co-sponsors, Paulsen and Wisconsin Democrat Ron Kind, "adopted the industry’s talking points in opposing the tax as a job killer that also took money away from research and development."
Consortium Chair Susan M. Wolf has been appointed to the National Academies' Committee on Science, Engineering, Medicine and Public Policy. This is the only committee that crosses all three academies – Sciences, Engineering, and Medicine – and includes the presidents of the three branches. According to their website, “the Committee is charged with the responsibility ‘to deliberate on initiatives for new studies in the area of science and technology policy, taking especially into account the concerns and requests of the President's Science Advisor, the Director of the NSF, the Chairman of the National Science Board, and the chairmen of key science and technology-related committees of the Congress.’” In addition to chairing the Consortium, Prof. Wolf is the McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine. She is an elected member of the National Academy of Medicine.
Last night, Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS), addressed the annual Biopharma Congress in Washington, DC. His talk was titled "The Need to Partner on Drug Innovation, Access and Cost." In it, Slavitt addressed what he called "pervasive" cost increases, noting: "Despite all the attention it has generated this year, Mylan’s Epipen is not even on our top 20 list for either high price increases or spending overall in 2015." Rising public outcry and state-level budget crises have led to congressional hearings about the reasons behind spiraling prices; the issue has been especially prominent during the current presidential election. Slavitt cautioned conference attendees, the majority of whom work in the pharmaceutical industry, that he's no longer comfortable defending Big Pharma. He noted that in the past, "I didn’t want this industry to be defined by its worst actors. . . but the more data that’s revealed, the more bad actors you find, and I’m telling you now: it’s too many." What is to be done? According to Modern Healthcare, despite policy positions held by both major-party candidates, significant change is unlikely because of the power of the pharmaceutical industry and ideological divisions in the legislative branch.